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Electrical Stimulation

Electrical Nerve Stimulation for Nerve Injury (REGAIN Trial)

N/A

Recruiting

Research Sponsored by Epineuron Technologies Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

REGAIN Trial Summary

This trial tests a new device that sends electrical pulses to nerves for 1 hour to see if it's safe and effective.

Who is the study for?

This trial is for individuals who have recently suffered a peripheral nerve injury. It's not suitable for those with ongoing nerve conditions like peripheral neuropathy or anyone with an active implanted device, such as a pacemaker.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a new temporary nerve stimulation system that delivers electrical therapy for one hour compared to a sham (inactive) version of the same system.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation, skin irritation, or temporary changes in nerve function due to the electrical therapy.

REGAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative incidence of adverse events

Sensory recovery

REGAIN Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatmentExperimental Treatment1 Intervention

Group II: Sham treatmentPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Epineuron Technologies Inc.Lead Sponsor

2 Previous Clinical Trials

51 Total Patients Enrolled

1 Trials studying Nerve Injury

25 Patients Enrolled for Nerve Injury

Media Library

Temporary Peripheral Nerve Stimulation System (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05721261 — N/A

Nerve Injury Research Study Groups: Active treatment, Sham treatment

Nerve Injury Clinical Trial 2023: Temporary Peripheral Nerve Stimulation System Highlights & Side Effects. Trial Name: NCT05721261 — N/A

Temporary Peripheral Nerve Stimulation System (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721261 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this clinical trial open for enrollment?

"This clinical trial is accepting 110 participants of ages 22-65 with nerve injury. To be considered, they must meet these criteria."

Answered by AI

Is this clinical study accepting participants who are older than 18 years of age?

"The age criteria for this research mandates participants to be below 65 years old and above the legal majority of 22."

Answered by AI

How extensive is the enrollment for this experimental protocol?

"Affirmative. Clinicaltrials.gov indicates that this research is currently searching for volunteers, having been initially posted on July 1st 2023 and last updated by the 12th of same month. 110 subjects are to be enrolled from two different sites."

Answered by AI

Is enrollment in this experiment still available for volunteers?

"Affirmative. The details hosted on clinicaltrials.gov confirms that this research study, which was first posted on July 1st 2023, is presently seeking volunteers for participation. A total of 110 individuals need to be sourced from 2 different medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

2023. "Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721261.